Name
Iodine Sella 2%/2.5% oral solution


What it is and what it is used for
As an antiseptic and disinfectant of the oral cavity
Treatment of iodine deficiency states in case of increased requirement or poor absorption.


What you need to know before taking the medicine
Hypersensitivity to the active substances or to any of the excipients.
Generally contraindicated in pregnancy (see Special warnings).

Do not use in children under 6 months.
As a mouthwash it should not be used in children under 6 years of age.


Warnings and precautions
Do not take the medicine for long periods of time.
Use, especially if prolonged, may give rise to sensitization phenomena. In this case, discontinue treatment and adopt appropriate therapeutic measures.
Since iodine and iodide can alter thyroid function, it is recommended to use with caution in subjects with thyroid disease, in patients over 45 years of age or with goiter.
Although iodine is required for the production of thyroid hormones, excessive amounts can cause hyperthyroidism or even paradoxical goiter and hypothyroidism.
In pediatric age, use only in cases of real need and under medical supervision.
It is advisable to avoid the use of gargle preparations in children, who are almost never able to gargle without swallowing a large part of the medicine (see Contraindications).
The medicine should not be used in adolescent patients due to the potential induction of acne and the effects on the thyroid.
Discontinue treatment at least 10 days before performing a scintigraphy with labeled iodine.
Treatment may alter the results of thyroid function tests, especially in premature infants.
After a short period of treatment without appreciable results, consult your doctor.

Avoid contact with eyes.


Possible side effects
Like all medicines, iodine can cause side effects, although not everybody gets them.
The following are the side effects of iodine. There are insufficient data to determine the frequency of the individual effects listed.
Pathologies of the haemolymphopoietic system
Eosinophilia, lymphadenopathy

Immune system disorders
Hypersensitivity

Endocrine pathologies
Hyperthyroidism (Basedow's disease), hypothyroidism, goiter.
Iodine can interfere with thyroid function tests.

Skin and subcutaneous tissue disorders
Urticaria, angioedema, skin haemorrhage
Inhalation of iodine vapors is very irritating to the mucous membranes

Metabolism and nutrition disorders
Metabolic acidosis

Psychiatric disorders
Depression, insomnia

Nervous system disorders
Metallic taste, headache

Cardiac and vascular pathologies
Hypotension, tachycardia

Respiratory, thoracic and mediastinal pathologies
Dyspnea, pulmonary edema, bronchospasm

Gastrointestinal disorders
Nausea, vomiting, diarrhea, abdominal pain

Renal and urinary disorders Renal failure
Renal failure

Reproductive system and breast disorders
Impotence

Systemic disorders and conditions related to the administration site
Fever

Injury, poisoning and procedural complications
Prolonged use may cause a series of adverse effects collectively called “iodism”, some of which may be due to hypersensitivity. These adverse effects include metallic taste, increased salivation, burning and soreness in the mouth; acute rhinitis, coryza-like syndrome, swelling and inflammation of the throat, irritation and swelling of the eyes and increased lacrimation may also occur. Pulmonary edema, dyspnea and bronchitis may develop.

Following the instructions in the leaflet reduces the risk of side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist .